All NCI clinical studies are carefully and regularly reviewed for participant safety, data quality, and scientific merit. NCI closed the Brooklyn site following the recommendation of an independent data monitoring committee that determined that it was not possible for the Cancer Institute of Brooklyn to overcome compliance and retention problems that affected the quality and scientific validity of its study data. No data from the Brooklyn site will be used in analyses of the PLCO study.

It is important to note, however, that the medical care given to individuals at the Cancer Institute of Brooklyn and its collaborating institutions is not under question.

The Cancer Institute of Brooklyn at Maimonides Medical Center, located in Brooklyn, New York, was one of the 10 centers across the United States enrolling people in this study. The other nine centers are open and actively recruiting participants in these cities: Denver, Colo.; Washington, D.C.; Honolulu, Hawaii; Detroit, Mich.; Minneapolis, Minn.; St. Louis, Mo.; Pittsburgh, Pa.; Salt Lake City, Utah; and Marshfield, Wis.

The approximately 7,000 study volunteers at Brooklyn were selected by chance (randomized) to receive the tests being studied (intervention group) or undergo the usual health care their doctors provide (control group). In the PLCO trial, different tests are being studied for each type of cancer:

• For prostate cancer, men have a digital rectal exam and a blood test for prostate-specific antigen (known as PSA).
• For lung cancer, men and women receive regular chest X-rays.
• For colorectal cancer, men and women are screened with a light scope called a flexible sigmoidoscope that lets doctors see inside a part of the colon.
• For ovarian cancer, women have a physical exam of the ovaries, a blood test for the tumor marker known as CA-125, and an ultrasound test called transvaginal ultrasound.

The results of all screening tests performed as part of the PLCO study on participants in the intervention group are routinely forwarded to the participants and their personal physicians. Because the study has closed in Brooklyn, study volunteers at that site will no longer be screened in the context of the study or be asked to answer an annual questionnaire about their health. Because the benefits of the tests being studied are unknown, researchers will regularly monitor participants at the remaining study centers and compare the number of cancers diagnosed and the number of cancer deaths in the intervention and control groups. Results will be made public at the completion of the trial, expected about 10 years after completion of enrollment.

The PLCO study will continue to enroll volunteers at centers across the United States until 148,000 men and women have participated. About 85,000 people have volunteered at the nine continuing PLCO sites so far.

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